Suppr超能文献

关于活性药物成分(API)在确定以微晶纤维素(MCC)作为唯一辅料制成的药用片剂中骨架材料的孔隙率、孔结构和体积模量方面的作用。

On the role of API in determining porosity, pore structure and bulk modulus of the skeletal material in pharmaceutical tablets formed with MCC as sole excipient.

作者信息

Ridgway Cathy, Bawuah Prince, Markl Daniel, Zeitler J Axel, Ketolainen Jarkko, Peiponen Kai-Erik, Gane Patrick

机构信息

Omya International AG, CH-4665 Oftringen, Switzerland.

Institute of Photonics, University of Eastern Finland, P.O. Box 111, FI-80101 Joensuu, Finland.

出版信息

Int J Pharm. 2017 Jun 30;526(1-2):321-331. doi: 10.1016/j.ijpharm.2017.04.038. Epub 2017 Apr 19.

Abstract

The physical properties and mechanical integrity of pharmaceutical tablets are of major importance when loading with active pharmaceutical ingredient(s) (API) in order to ensure ease of processing, control of dosage and stability during transportation and handling prior to patient consumption. The interaction between API and excipient, acting as functional extender and binder, however, is little understood in this context. The API indomethacin is combined in this study with microcrystalline cellulose (MCC) at increasing loading levels. Tablets from the defined API/MCC ratios are made under conditions of controlled porosity and tablet thickness, resulting from different compression conditions, and thus compaction levels. Mercury intrusion porosimetry is used to establish the accessible pore volume, pore size distribution and, adopting the observed region of elastic intrusion-extrusion at high pressure, an elastic bulk modulus of the skeletal material is recorded. Porosity values are compared to previously published values derived from terahertz (THz) refractive index data obtained from exactly the same tablet sample sets. It is shown that the elastic bulk modulus is dependent on API wt% loading under constant tablet preparation conditions delivering equal dimensions and porosity. The findings are considered of novel value in respect to establishing consistency of tablet production and optimisation of physical properties.

摘要

在向药物片剂中载入活性药物成分(API)时,片剂的物理性质和机械完整性至关重要,以确保在患者服用前的运输和处理过程中易于加工、控制剂量并保持稳定性。然而,在这种情况下,作为功能增强剂和粘合剂的API与辅料之间的相互作用却鲜为人知。在本研究中,将API吲哚美辛与微晶纤维素(MCC)以不断增加的载入量进行混合。由不同压缩条件(从而压实程度)导致的具有可控孔隙率和平片厚度的条件下,制成具有特定API/MCC比例的片剂。采用压汞法来确定可及孔隙体积、孔径分布,并在高压下观察弹性侵入-挤出区域,记录骨架材料的弹性体积模量。将孔隙率值与先前发表的、从完全相同的片剂样品集获得的太赫兹(THz)折射率数据得出的值进行比较。结果表明,在制备尺寸和孔隙率相同的片剂的恒定条件下,弹性体积模量取决于API的重量百分比载入量。这些发现对于建立片剂生产的一致性和优化物理性质具有新的价值。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验